Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PCC115
Study information
Scientific title
Acronym
Study hypothesis
The Second Bradford Community Stroke Trial seeks to assess the neglected area of psychosocial functioning in stroke patients and their families. Patients are randomly allocated to a control or intervention group. The latter group receive regular visits from one of the geriatric department liaison nurses who provide information, advice and support focusing on emotional and social recovery rather than physical function. Quantitative assessments are undertaken at 3, 6 and 12 months. However, there is a concern that the quantitative measures used may not be sufficiently comprehensive to capture the range of outcome experiences for the patient and carer. An additional qualitative evaluation would assess more fully the meanings and experience of their strokes for the patients in the two trial groups and thus facilitate:
1. A more detailed picture of the psycho-social difficulties experienced by stroke patients and their carers;
2. A better understanding of the nature of the intervention provided by the liaison nurses;
3. A more comprehensive evaluation of the trial outcome with a balance between quantitative and qualitative outcome assessments.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular diseases: Cerebrovascular disease
Intervention
1. Regular visits from one of the geriatric department liaison nurses who provide information, advice and support focusing on emotional and social recovery rather than physical function
2. Standard care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/1994
Overall trial end date
09/06/1995
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing trabeculectomy
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/07/1994
Recruitment end date
09/06/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bradford Hospitals NHS Trust
Bradford
BD5 0NA
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary